Cai Shangli, Lu Huafei, Bai Zhihua, Wu Renrong, Zhao Jingping
Mental Health Institute of the Second Xiangya Hospital, National Technology Institute of Psychiatry, Key Laboratory of Psychiatry and Mental Health of Hunan Province, Central South University, Hunan, People's Republic of China ; Janssen Research and Development, Beijing, People's Republic of China.
Janssen Research and Development, Beijing, People's Republic of China.
Neuropsychiatr Dis Treat. 2015 Jul 23;11:1817-34. doi: 10.2147/NDT.S84833. eCollection 2015.
Previous meta-analyses have compared paliperidone extended-release (ER) tablets with other antipsychotics, but none have involved Chinese patients or studies from People's Republic of China. Further, the results of these meta-analyses may not be applicable to Chinese patients. In the present study, we evaluated the efficacy, safety, and acceptability of paliperidone ER compared with other second-generation antipsychotics (SGAs) for Chinese patients with schizophrenia.
Randomized controlled studies of paliperidone ER and other SGAs as oral monotherapy in the acute phase treatment of schizophrenia were retrieved from Medline, Embase, and the Cochrane Library (CENTRAL), as well as from Chinese databases including the China National Knowledge Infrastructure, Wanfang, and VIP Information/Chinese Scientific Journals Database. We pooled data on response rates, chance of withdrawal due to adverse events, probability of adverse events, and odds of withdrawal for any reason.
Fifty randomized controlled trials were identified. The response rate for paliperidone ER was significantly higher than that of other pooled SGAs (risk ratio [RR] 0.83, 95% confidence interval [CI] 0.72-0.96) and ziprasidone (RR 0.57, 95% CI 0.39-0.82). Paliperidone ER significantly reduced the chance of withdrawal due to adverse events and the chance of any adverse events compared with other pooled SGAs (RR 0.32, 95% CI 0.17-0.58 and RR 0.88, 95% CI 0.79-0.97) and risperidone (RR 0.31, 95% CI 0.14-0.67 and RR 0.70, 95% CI 0.57-0.86). The incidence of extrapyramidal symptoms on paliperidone ER was comparable with other pooled SGAs (RR 0.94, 95% CI 0.66-1.35) and significantly lower than that of risperidone (RR 0.56, 0.41-0.77) but higher than that of olanzapine (RR 1.88, 95% CI 1.05-3.36). Paliperidone ER was superior to other pooled SGAs (RR 0.32, 95% CI 0.21-0.49 and RR 0.50, 95% CI 0.35-0.72) and olanzapine (RR 0.23, 95% CI 0.15-0.33 and RR 0.33, 95% CI 0.23-0.47) as far as weight gain and somnolence were concerned. Further, prolactin-related adverse events caused by paliperidone ER were comparable with other pooled SGAs (RR 1.30, 95% CI 0.73-2.33), but outnumbered those caused by olanzapine (RR 7.53, 95% CI 2.05-27.71).
Paliperidone ER is efficacious, safe, and well accepted when compared with other pooled SGAs for the treatment of Chinese patients with schizophrenia.
既往的荟萃分析比较了帕利哌酮缓释片与其他抗精神病药物,但均未纳入中国患者或来自中华人民共和国的研究。此外,这些荟萃分析的结果可能不适用于中国患者。在本研究中,我们评估了帕利哌酮缓释片与其他第二代抗精神病药物(SGA)相比,用于治疗中国精神分裂症患者的疗效、安全性和可接受性。
从Medline、Embase和Cochrane图书馆(CENTRAL)以及中国数据库(包括中国知网、万方和维普资讯/中文科技期刊数据库)中检索关于帕利哌酮缓释片和其他SGA作为口服单一疗法用于精神分裂症急性期治疗的随机对照研究。我们汇总了关于缓解率、因不良事件停药的几率、不良事件的概率以及任何原因停药的比值的数据。
共识别出50项随机对照试验。帕利哌酮缓释片的缓解率显著高于其他汇总的SGA(风险比[RR]0.83,95%置信区间[CI]0.72 - 0.96)和齐拉西酮(RR 0.57,95% CI 0.39 - 0.82)。与其他汇总的SGA(RR 0.32,95% CI 0.17 - 0.58和RR 0.88,95% CI 0.79 - 0.97)以及利培酮(RR 0.31,95% CI 0.14 - 0.67和RR 0.70,95% CI 0.57 - 0.86)相比,帕利哌酮缓释片显著降低了因不良事件停药的几率和任何不良事件的几率。帕利哌酮缓释片锥体外系症状的发生率与其他汇总的SGA相当(RR 0.94,95% CI 0.66 - 1.35),显著低于利培酮(RR 0.56,0.41 - 0.77)但高于奥氮平(RR 1.88,95% CI 1.05 - 3.36)。就体重增加和嗜睡而言,帕利哌酮缓释片优于其他汇总的SGA(RR 0.32,95% CI 0.21 - 0.49和RR 0.50,95% CI 0.35 - 0.72)以及奥氮平(RR 0.23,95% CI 0.15 - 0.33和RR 0.33,95% CI 0.23 - 0.47)。此外,帕利哌酮缓释片引起的与催乳素相关的不良事件与其他汇总的SGA相当(RR 1.30,95% CI 0.73 - 2.33),但多于奥氮平引起的此类不良事件(RR 7.53,95% CI 2.05 - 27.71)。
与其他汇总的SGA相比,帕利哌酮缓释片在治疗中国精神分裂症患者时有效、安全且耐受性良好。